Status:
COMPLETED
Ph I SU011248 + Irinotecan in Treatment of Pts w MG
Lead Sponsor:
Duke University
Collaborating Sponsors:
Pfizer
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Primary Objectives To determine maxi tolerated dose \& dose limiting toxicity of SU011248 + Irinotecan in recurrent MG pts not on EIAEDs To characterize safety \& tolerability of SU011248 + Irinotecan...
Detailed Description
Primary interest for combining SU011248 w irinotecan in malignant glioma pts derives from dramatic anti-tumor activity recently demonstrated among RMG pts treated w humanized anti-VEGF monoclonal anti...
Eligibility Criteria
Inclusion
- Pts confirmed GBM, GS, AA, AO \& AOA w recurrent disease following standard therapy consisting of at least external beam XRT \& temo chemo
- Pts not had tumor biopsy \<1 week/surgical resection \<2 weeks prior to starting study drug
- Pts should be on non-increasing dose of steroids \>7 days prior to obtaining baseline Gd-MRI of brain
- Age \>18yrs
- KPS \>70
- ANC \>1.5 x 10 9/L
- Hgb \>9 g/dL
- Platelets \>100 x 10 9/L
- AST/SGOT \& ALT/SGPT \<2.5 x ULN
- Serum bilirubin \<1.5 x ULN
- Serum CA \<12 mg/dL
- Serum creatinine \<1.5 x ULN/measured 24-hr CrCl\>50mL/min/1.73m\^2
- Pt has ability to understand \& provide signed informed consent that fulfills IRB guidelines
Exclusion
- Prior gr3/\>toxicity/failure to CPT-11 therapy
- Prior Sunitinib malate therapy
- Concurrent administration of EIAEDs
- Major surgery \<2 weeks of enrollment
- History of impaired cardiac function
- Other clinically significant cardiac diseases
- Uncontrolled diabetes
- Active/uncontrolled infection requiring intravenous antibiotics
- Impairment of GI function/GI disease that may significantly alter absorption of Sunitinib malate Sutent
- Acute/chronic liver/renal disease
- Cerebrovascular accident/transient ischemic attack \<6mths of study enrollment
- Pulmonary embolism \<6mths of study enrollment
- Pre-existing thyroid abnormality w thyroid function that can not be maintained in normal range w medication
- Pts taking warfarin sodium
- Pts have received chemo ≤4wks to starting study drug unless they have fully recovered from all anticipated side effects of such therapy
- Pts have received immunotherapy ≤2wks to starting study drug/have not recovered from side effects of such therapy
- Pts have received investigational drugs ≤2wks to starting study drug unless they have fully recovered from all anticipated side effects of such therapy
- Pts have received XRT ≤4wks to starting study drug unless they have fully recovered from all anticipated side effects of such therapy
- Pts have undergone major non-CNS surgery ≤2wks to starting study drug/pts who have not recovered from side effects of such therapy
- Cardiac pacemaker
- Ferromagnetic metal implants other than those approved as safe for use in MR scanners
- Claustrophobia
- Obesity
- Female pts who are pregnant/breast feeding/adults of reproductive potential not employing effective method of birth control
- Known diagnosis of HIV
- History of another primary malignancy that is currently clinically significant/currently requiring active intervention
- Pts unwilling to/unable to comply w protocol
- Existing intra-tumoral hemorrhage
- Concurrent participation in another clinical trial except for supportive care/non-treatment trials
- Other severe acute/chronic medical/psychiatric condition/lab abnormality that may increase risk associated w study participation/study drug administration/ may interfere w interpretation of study results, \& in judgment of investigator would make subject inappropriate for entry into this study
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00611728
Start Date
March 1 2008
End Date
September 1 2010
Last Update
July 21 2014
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710